Determine clinical impact of GEP results on the increase/decrease of surgical excision margins and follow-up frequency.

Assess the ability of the 40-GEP test to significantly improve metastatic risk prediction of NCCN, AJCC8, and BWH staging systems when included.

The management of patient with melanocytic lesions is dependent on the diagnosis with guidelines defining treatment protocols for benign nevi and malignant melanomas. Even though diagnostic discordance and diagnostic ambiguity have been previously established, the real-world impact on patient management is not well understood.Using an exhaustive review process by multiple dermatopathologists and a simulated patient treatment model, this study reveals that diagnostic discordance and ambiguity may be more common that previously reported and identifies significant variation in patient treatment in these lesions.

Diagnostic GEP tests help guide clinical decision-making in a variety of diagnostically ambiguous or clinicopathologically discordant scenarios.

The high accuracy and clinical utility of the 23-GEP test demonstrated across multiple prior studies are applicable to the Medicare-eligible population.

This study shares three-year outcomes data from Castle’s prospective, multicenter study of patients with melanoma who were being considered for an SLNB (n=322). In the study, at three years, all patients with a low-risk DecisionDx-Melanoma test result were recurrence free (recurrence free survival of 100%). The performance data shared in this presentation, in conjunction with previous validation and performance studies, show DecisionDx-Melanoma as an accurate and precise clinical tool that can identify patients who may safely forego SLNB, reducing the number of unnecessary SLNBs performed (by ~25% in this study alone) and the associated costs and risks of complications that accompany them.

ART guidance is not determined by the presence of specific clinicopathologic factors, with treated and untreated patients sharing the same risk factor profiles. cSCC risk determination based on NCCN recommendations for clinical factor assessment results in inconsistent use of ART. Including tumor biology-based prognostic information from the 40-GEP refines risk and identifies patients who are most appropriate and likely to benefit from ART, and those that can consider deferring ART.

The 40-GEP test demonstrates accurate, independent, clinically actionable stratification of metastatic risk and improves predictive accuracy when integrated into risk classification systems. The improved accuracy of risk assessment when including tumor biology via the 40-GEP test ensures more risk-aligned, personalized patient management decisions.

Demonstrate that the 31-GEP offers significant prognostic value in addition to SLN status to help identify patients at the highest risk of tumor recurrence.

Combining clinicopathologic staging with the 40-GEP test allows for more accurate prognostic staging of cSCC tumors; this, in turn, improves precision in multidisciplinary treatment recommendations, including the use of ART. The utility of 40-GEP testing has been demonstrated in low-, higher-, and highest-stage cSCC tumors. Additionally, 40-GEP testing has shown greater specificity than current clinicopathologic guidelines in identifying patients at highest risk of nodal or distant metastasis who would most likely benefit from ART, as well as lower risk patients who would benefit less from such therapy. Appropriate use of 40-GEP testing involves a shared decision-making model between the multidisciplinary team and the patient with cSCC, taking into consideration many factors, such as the patient’s risk of metastasis, tumor and nontumor characteristics, and individual preferences.

TissueCypher optimized adherence to clinical guidelines for surveillance and treatment of both BE patients at high and low risk for disease progression. Use of the test can enable physicians to make risk-aligned management decisions, leading to improved patient health outcomes.